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Shenzhen WeCheck CTS Co Ltd

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Preshipment Inspection > Dispenser Pedometer Blood Pressure Heart Medical Device Kiosk Infrared Thermometer Heart Pulse Rate Temp Resp Monitor

How to do Pre-shipment QC inspections for Dispensers, Pedometers, Blood Pressure Monitors, Heart Rate Monitors, Medical Devices, Kiosks, Infrared Thermometers, Heart Pulse Monitorss, Temp RESP Monitors etc.?

  • Measurements & sizes check
  • Aesthetic, visual defects, workmanship, surface and function check
  • Packaging, safety and drop tests
  • Quantity & assortment verifying
  • Product specs, and special requirements check
  • Labels, markings, logos & barcodes check
  • On-site safety, regulation & function testing

Most of such devices are made in Shenzhen, or the nearby cities. Our inspectors can be on-site at 48hours notices:

Midical device Inspection

As an random examples, please find below for a checklist for Thermometer Pre-shipment inspection:

Perform a function test.-Of the on/off switch, dimmer switch, the sensor and all other functions listed on the item’s box.- (3Pcs) For FHT5, Special button that activates 8hours instead of spec: 4 hours time lap, but same as approval sample; PASSED
Functional inspection
1) Press the power button and verify that one beep is heared, and all the segments are shown.
2) Only after you hear two beeps the device is ready for measurement, check that the display shows as default C or F scale according the reference.
5) verify that after operating the device, there are none of following segments: ERR 1, ERR 2, ERR 3 or low battery icon- II (200Pcs)
1. Packging inspection verify the presence of the following component for each packed product unites. According reference sample
a) 1 thermometer b) 1 IFU - user manual c) 1 gift box / or blister d) 1 Insert Graphics e) Two triple A batteries -Each product have it’s own combination of packeging, so you need to comper to the reference sample or photo - II (200Pcs)
2. Packging inspection 1. Check the IFU printing quality and record the IFU Rev 2. Check that all the packge components are well
folded and are intact. 3. check that the color of packging componants are similar to reference.
4. check the printing on the packging components are similar to reference. 5. check the packging orientation. -All color and
printing must be compared to approved reference. - II (200Pcs)
Assembly inspection 1) Check that the plastic parts are not loose and there is no space between plastic parts. (The gap should be less then 0.5 mm) Note: The Check must be done with a Filler gauge 2) Check that the silicon buttons are well assembled. 3) Check that the Probe silicon housing is properly inserted in his slot. 4) Check that the silicon parts color is similar to reference. 5) Check that the LCD is clean and intact. 6) Check the LCD lens printing in comparison to reference.- - II (200Pcs) PASSED
Static test (accuracy)
1) Prepare a water bath at 37C or 98.6F Celsius (verify the water temp’ by using an external calibrated thermometer
2) Open the battery cover 3) Press the Reset button with soft conductive keypad.
4) While still pushing the reset button, press and release the Power button, a beep will be heard and the display will show 711 for fahrenheit default or 712 for Celsius default or 713 for Celsius only.
5) Immediately release the key pad.
6) The display will show room temperature on
the screen.
7) Place the thermometer in 37C or 98.6F water bath and wait 10 minutes.
8) After 10 minutes, check the temperatures if it is within the acceptable range.
9) Acceptable range is 37C +-0.2C or 98.6F +-0.36F,
10) That is means acceptable range is between 36.8C to 37.2C or 98.24F to 98.96F
11) Turn off the device. Attention: after test is complete device must be turned OFF, otherwise it remains ON.-Note: By pressing the power and reset button together, it is possible to get into 3 different modes: - II (200Pcs)
Labeling 1) Quick start label: Check caption of quick start is according to reference. 2) Rating label: Check caption of Rating label is
according to the compatible product sample reference. 3) Check that the lot number on rating label is compatible to COC, Packing list, Master box, and Inner box.- - II (200Pcs)
Record All the lot numders that within the inspected PO in the inspection report. If there are more then one PO record each lot number under his specific PO-Not: You can inspect defrent lots from the same product typ in one inspection report. - S2 (8 Pcs) PASSED
Perfom a rub test and Adhesive Test for printing: Rub test: 15 second with cloth soaked with Water and 15 second with cloth
soaked with Hexane. Adhesive test: with 3M tape.-The priting should still be clearly readable after testing-S2 (8 Pcs)

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